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The Prism Adaptation Study (PAS)
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Study NCT00000121   Information provided by National Eye Institute (NEI)
First Received: September 23, 1999   Last Updated: September 16, 2009   History of Changes

September 23, 1999
September 16, 2009
March 1984
 
 
 
Complete list of historical versions of study NCT00000121 on ClinicalTrials.gov Archive Site
 
 
 
The Prism Adaptation Study (PAS)
 

To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of surgery for acquired esotropia, a type of strabismus.

To determine whether patients who respond to prism adaptation by developing a new stable angle of -deviation have a better surgical result than do patients who do not respond to prism adaptation.

To determine whether patients who respond to prism adaptation are more accurately corrected by operating for the prism-adapted angle or the original angle of deviation.

To determine the usefulness of certain input variables (e.g., age at the time of surgery, size of the deviation, visual acuity, binocular function, refractive error) in predicting which patients are more likely to benefit from prism adaptation.

Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months) accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is done primarily to attain functional use of the two eyes together. The cosmetic aspect of the surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to accomplish the primary goal, and in some cases even three and four operations are needed.

Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses for about a month before surgery led to good results after a single operation in more than 90 percent of patients. These uncontrolled preliminary studies pointed to the need for a multicenter, randomized, controlled clinical trial designed to prove or disprove scientifically the beneficial effect of prisms.

The Prism Adaptation Study was a double randomization trial involving 286 patients. Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of the patients who responded to the prisms, one-half were randomly selected to have surgery based on the amount of prism required to stabilize the deviation, and the other half had surgery based on the amount of esotropia originally measured. Patients who did not respond to the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths of the patients who did not undergo prism adaptation.

Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An independent examiner, masked to the treatment assignment, evaluated the patient at the 6-month followup. The results were analyzed to determine whether the outcome was better in patients who underwent prism adaptation or in those who underwent conventional treatment. Because the examiner did not know what type of treatment a patient had received, he or she would have no bias in evaluating the results.

Phase III
Interventional
Treatment, Randomized, Efficacy Study
Esotropia
Device: Prisms in Eyeglasses
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
May 1989
 

An eligible male or female must have been age 3 years or older (adults were included) and must have had esotropia that occurred at age 6 months or older, with no history of previous eye muscle surgery.

Both
3 Years and older
 
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00000121
 
NEI-20
National Eye Institute (NEI)
 
 
National Eye Institute (NEI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP